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Stepwise TIPS Based on a Controlled-Expansion Stent System: A Multicenter Randomized Controlled Trial

Stepwise TIPS Based on a Controlled-Expansion Stent System: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125766
Enrollment
Unknown
Registered
2026-05-31
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal hypertension

Interventions

Stepwise TIPS:stepwise TIPS
Control group:Standard diameter TIPS

Sponsors

Zhongshan hospital,Fudan university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–75 years, with no gender restriction; 2. Clinically or pathologically confirmed diagnosis of cirrhotic portal hypertension, with a prior history of endoscopically confirmed esophagogastric variceal rupture and recurrent bleeding after receiving standard therapy; 3. The patient and their family members have agreed to participate in the clinical trial and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe liver failure: Child-Pugh score > 12 or MELD score > 19; 2. Prior history of hepatic encephalopathy (HE): recurrent spontaneous overt HE within 3 months before the procedure; 3. Malignancy: concomitant hepatocellular carcinoma (HCC) beyond the Milan criteria or other malignancies with an expected survival < 12 months; 4. Severe cardiac or renal dysfunction: New York Heart Association (NYHA) class III–IV heart failure, moderate-to-severe pulmonary hypertension, or uncontrolled renal failure; 5. Portal vein thrombosis (PVT): cavernous transformation of the portal vein or extensive PVT precluding the establishment of an interventional access; 6. Anatomical abnormalities: severe anatomical variations of the intrahepatic vasculature making TIPS unsuitable; 7. Psychiatric disorders: inability to accurately assess neuropsychiatric status; 8. Prior surgical treatment for portal hypertension: history of surgical shunt, devascularization, or splenectomy; 9. Previous TIPS or liver transplantation.

Design outcomes

Primary

MeasureTime frame
Overt hepatic encephalopathy ;

Countries

China

Contacts

Public ContactJianjun Luo

Zhongshan hospital,Fudan university

luo.jianjun@zs-hospital.sh.cn+86 153 0080 0662

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026